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Title: Newly Published Review of Six Unusual Patient Cases Finds the Antiepileptic Drug Keppra May Help in Patients with Developmental Disability

"Newly Published Review of Six Unusual Patient Cases Finds the Antiepileptic Drug Keppra May Help in Patients with Developmental Disability"

LITTLE ROCK, AK -- September 5, 2002 -- In an article published in the current issue of Epilepsy and Behavior, a review of six separate patient cases showed that the second-generation antiepileptic (AED) drug Keppra (levetiracetam) may be effective in patients with developmental disability who have epilepsy. Two of the developmentally disabled epilepsy patients studied became seizure-free after beginning Keppra therapy, while the other four had seizure reductions ranging from 71 to 92 percent over a three- to 10-month period. None of the six patients reported adverse events, and three showed improvements in behavior. "Epilepsy in the developmentally disabled is typically even more difficult to treat than in other patients, so physicians tend to settle for poor treatment outcomes," said Gordon Gibson, M.D., author of the case review and a neurologist in private practice in Little Rock, Ark., who specializes in the treatment of epilepsy in the developmentally disabled. "This may mean that we can raise our expectations of epilepsy treatment in the developmentally disabled, and that Keppra should be considered for these patients." Patients Had Failed Previous AED Treatments All six patients lived in a chronic care facility and had periodic staff and physician assessments, which included seizure calendars and reports on adverse events and behavior. Four male and two female cases were examined, and patients ranged in age from 25 to 51 years. All patients had failed treatment with multiple AEDs. At the time of Keppra initiation, patients were taking a mean of 2.5 AEDs (range, 1-4). Some patients had suffered significant side effects from prior AEDs, including lethargy, confusion, ataxia (a disorder that affects coordination), behavioral disturbances and sedation. Patients received Keppra at a starting dose of 250 mg twice a day, except for patient six, who began at 500 mg twice a day due to more than 20 seizures in the prior two months despite an intensive treatment regimen. Patients received physician visits at intervals ranging from one to three months. Case 1: Seizure-free Patient one was a 35-year-old black woman with severe mental retardation and a lifelong history of poorly controlled partial complex seizures with and without secondary generalization. Seizures did not respond to several AEDs. In the three months prior to beginning treatment with Keppra, she had 12 seizures. At a follow-up visit three months after beginning treatment with Keppra, she had not experienced a seizure and has remained on the starting dose of 250 mg twice a day. Her caregiver noted a significant improvement in her level of alertness. Case 2: Seizure-free Patient two was a 51-year-old white man with mental retardation secondary to Down syndrome. With a lifelong history of generalized tonic-clonic seizures, he had failed treatment with two AEDs and was experiencing severe side effects from his current medication. Keppra was added to his treatment regimen, and a taper of the other medication was begun. At a follow-up visit three months later, he was seizure-free and the side effects had stopped. According to his caregiver, since beginning treatment with Keppra, ''He's gotten his personality back.'' Case 3: 92 Percent Seizure Improvement Patient three was a 35-year-old developmentally disabled black man with longstanding partial and secondarily generalized seizures. Despite various combinations of AEDs, his seizures continued. In the four months prior to the addition of Keppra, the patient had 25 seizures. Keppra was added to the patient's regimen of four AEDs, one of which was discontinued two weeks after beginning treatment with Keppra. Seizure frequency had diminished dramatically to only two seizures in the four months prior to completion of the case review, an improvement of 92 percent. There were no significant side effects. Case 4: 76 Percent Seizure Improvement Patient four was a 26-year-old white man with mental retardation, cerebral palsy, and lifelong generalized tonic-clonic seizures. Several AEDs were used without success, and his seizure frequency was variable, ranging from zero to five per month. In the 10 months prior to beginning treatment with Keppra, he had 17 seizures. In the 10 months since starting treatment with Keppra, he had only four seizures, representing an improvement of 76 percent. He has had no side effects since the addition of Keppra. Case 5: 72 Percent Seizure Reduction Patient five was a 33-year-old white man with mental retardation, cerebral palsy, and lifelong partial and secondarily generalized seizures. Previous treatment with AEDs proved ineffective, as he experienced 18 seizures in the three months prior to beginning treatment with Keppra. Three months after Keppra was added to a combination of two other AEDs, the patient's caregiver noted that he was less aggressive and anxious and more social. The patient had only five seizures during that three-month period, representing a 72 percent seizure reduction. Case 6: 73 Percent Seizure Reduction Patient six was a 25-year-old white woman with cerebral palsy, mental retardation, and uncontrolled generalized tonic-clonic seizures since age five months. In the 12 months preceding her follow-up visit, she had an average of 12.2 seizures/month while being treated with three AEDs. Following the addition of Keppra, her seizures decreased 73 percent to an average of 3.3/month. Keppra tablets are currently approved by the U.S. Food and Drug Administration for the adjunctive treatment of partial onset seizures in adults with epilepsy. Keppra use is associated with the occurrence of central nervous system adverse events, including somnolence and fatigue, coordination difficulties, and behavioral abnormalities, and with minor, but statistically significant, hematological abnormalities. Keppra dosing must be individualized according to renal function status. SOURCE: Gordon Gibson, M.D

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